Medtronic Recalls Endo GIA Stapler Loading Units Due to Missing Sled
Medtronic is recalling 171,271 Endo GIA Auto Suture Universal Articulating Loading Units because a missing sled component may prevent staple formation, leading to bleeding or leakage.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that can lead to bleeding or leakage of luminal contents, which constitutes a significant injury risk.
Plain-English summary
Medtronic is recalling 171,271 units of the Endo GIA Auto Suture Universal Articulating Loading Unit 60mm - 3.5mm (Item Code 030458). The recall is due to a potential defect where the device may be missing a sled component. This component is responsible for staple deployment.
If the sled is missing, the device may fail to form a staple line when tissue is divided. This failure can lead to bleeding or the leakage of luminal contents. The affected lots are distributed worldwide and in the US nationwide.
Healthcare providers and facilities should check their inventory for the specific lot numbers and GTINs listed in the recall notice. If the affected units are found, they should be removed from use and returned to Medtronic according to the recall instructions.
The recalled product
- Product
- Endo GIA" Auto Suture" Universal Articulating Loading Unit 60mm - 3.5mm ( Item Code 030458) Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue between the two,
- Manufacturer
- COVIDIEN MEDTRONIC
- Affected units
- 171,271
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots: N7L0911KX
- N7M0067KX
- N7F0631KX
- N7L0465KX
- N7L0117KX
- N7L0768KX
- N7M0314KX
- N7L1075KX
- N7M0646KX
- N7M0740KX
- N7M0972KX
- N8A0172KX
- N8A0539KX
- N8A0679KX
- N8A0910KX
- N8A0961KX
- N8B0054KX
- N8B0099KX
- N8C0008KX
- N8C0205KX
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by COVIDIEN MEDTRONIC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 40 products in this recall →Related recalls
Same manufacturer · COVIDIEN MEDTRONIC
See all →- SevereMedtronic Endo GIA Vascular Reloads Recalled for Missing Sled Component
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- SevereMedtronic Tri-Staple 2.0 Reloads Recalled for Missing Sled Component
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- SevereMedtronic Endo GIA Stapler Recall Due to Missing Sled Component
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- SevereEndo GIA 60 mm Articulating Vascular/Medium Loading Unit Recalled for Missing Sled
FDA (Devices) · 2018-07-25
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